Soft Tissue Augmentation Using Deepithelialized Free Gingival Graft Compared to Connective Tissue Graft in Management of Miller Class I and II Gingival Recession.
1 other identifier
interventional
28
1 country
1
Brief Summary
The aim of this study will be to clinically assess the soft tissue augmentation achieved by the de-epithelialized free gingival graft with coronally advanced flap versus the subepithelial connective tissue graft with coronally advanced flap as root coverage procedures for management of patients with Miller class I and II gingival recession.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 6, 2017
CompletedFirst Posted
Study publicly available on registry
July 11, 2017
CompletedStudy Start
First participant enrolled
October 17, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 27, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 27, 2019
CompletedAugust 13, 2019
August 1, 2019
1.6 years
July 6, 2017
August 11, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Gingival Thickness
Thickness of the gingival tissues 2 mm from the free gingival margin
6 months
Secondary Outcomes (7)
Percentage of root coverage
6 months
Root coverage esthetic score
6 months
Post-Operative Pain
Two weeks
Post-operative stress
Two weeks
Post-operative bleeding
Two weeks
- +2 more secondary outcomes
Study Arms (2)
Subepithelial connective tissue graft
ACTIVE COMPARATORPatients will receive a coronally advanced flap surgery with a subepithelial connective tissue graft for recession coverage.
De-epithelialized free gingival graft
EXPERIMENTALPatients will receive a coronally advanced flap surgery with a de-epithelialized free gingival graft for recession coverage.
Interventions
The connective tissue graft is obtained by a single line incision from the palate.
The connective tissue graft is obtained by deepithelialization of a free gingival graft.
Eligibility Criteria
You may qualify if:
- Patients 18 years or older.
- Periodontally and systemically healthy.
- Buccal recession defects classified as either Miller class I or II.
- Presence of identifiable Cementoenamel juction (Zucchelli et al., 2010).
- Clinical indication and/or patient request for recession coverage.
- O'Leary index less than 20% (O'Leary et al., 1972).
You may not qualify if:
- Miller class III or IV recession defects.
- Pregnant females.
- Smokers as smoking is a contraindication for any plastic periodontal surgery (Khuller, 2009).
- Handicapped and mentally retarded patients.
- Patients undergoing radiotherapy.
- Teeth with cervical restorations, abrasion.
- Presence of systemic disease that would affect wound healing.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (1)
Faculty of Oral and Dental Medicine
Cairo, 12114, Egypt
Related Publications (1)
Zucchelli G, Mele M, Stefanini M, Mazzotti C, Marzadori M, Montebugnoli L, de Sanctis M. Patient morbidity and root coverage outcome after subepithelial connective tissue and de-epithelialized grafts: a comparative randomized-controlled clinical trial. J Clin Periodontol. 2010 Aug 1;37(8):728-38. doi: 10.1111/j.1600-051X.2010.01550.x. Epub 2010 Jun 24.
PMID: 20590963BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Azza Ezz Elarab, Phd
Professor
- STUDY DIRECTOR
Noha Ghallab, Phd
Professor
- STUDY DIRECTOR
Weam El Battawy, Phd
Lecturer
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- CARE PROVIDER, OUTCOMES ASSESSOR
- Masking Details
- Single blinded: * Blinding of the participants is not applicable. * Blinding of the operator is not applicable. * Outcome assessor (primary and secondary outcomes) \& biostatistician will be blinded.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
July 6, 2017
First Posted
July 11, 2017
Study Start
October 17, 2017
Primary Completion
May 27, 2019
Study Completion
July 27, 2019
Last Updated
August 13, 2019
Record last verified: 2019-08
Data Sharing
- IPD Sharing
- Will not share